Ferrous Fumarate; Folic Acid; Multivitamins
Indications: Anemia, iron-deficiency
CLINICAL PHARMACOLOGY:
Vitamins and dietary minerals are fundamentally involved in vital metabolic processes, where they usually serve as oxidizing and reducing agents and as factors in various enzyme systems.
These essential micronutrients are so closely interrelated that the lack of any one may affect the body requirements of others.
Metabolic Functions of Inorganic Ions
Iron: Iron plays an important role in oxygen and electron transport. Iron may be functional (in hemoglobin, myoglobin, heme enzymes, and cofactor and transport iron) or stored as ferritin and hemosiderin in the liver, spleen, bone marrow, and reticuloendothelial system. The hemoglobin (0.34 percent iron) content of blood is about 14 to 17 g per 100 ml in adult males; in adult females it ranges between 12 and 14 g. Following ingestion, ferrous iron forms low molecular chelates with amino acids, ascorbic acid, and sugars which may be solubilized and absorbed before they reach the distal small intestine. Iron is probably absorbed passively into the mucosal layer of the small intestine, then transferred actively to transferrin where it is incorporated into red blood cells in bone marrow or into all body cells. Transferrin iron may also be stored in bone marrow liver and spleen. Iron is removed from the body in the urine, bile, sweat, feces, and via desquamation of cells.
Copper: Copper is an essential enzyme co-factor in the utilization of iron in hemoglobin synthesis.
Magnesium: Magnesium is an enzyme activator--certain peptidases and phosphatases require magnesium for maximal activity as do virtually all reactions involving adenosine triphosphate.
Metabolic Functions of the Vitamins
Fat Soluble Vitamins: These tend to be stored in the body; their precise mode of action is largely unknown.
Vitamin A: essential to the production and regeneration of the visual purple of the retina; maintenance of the integrity of epithelial tissue; lysosome stability.
Vitamin D: functions in bone metabolism by regulating the intestinal absorption of calcium and phosphorus.
Vitamin E: intracellular antioxidant, important to the stability of biologic membranes.
Water Soluble Vitamins: except for vitamin B12, these micronutrients are not stored in the body.
B Complex Vitamins: (thiamine, riboflavin, pyridoxine, niacinamide, pantothenic acid, vitamin B12 folic acid): these function, either alone or as structural components of more complex molecules, in catalytic systems where they usually function as coenzymes in carbohydrate, protein, or amino acid metabolism, synthesis of DNA and other molecules, maturation of RBCs, nerve cell function, or oxidation-reduction reactions.
Vitamin C: a coenzyme, essential to osteoid tissue; collagen formation; vascular function; tissue respiration and wound healing; facilitates absorption of iron.
INDICATIONS AND USAGE:
Therapeutic Formula Vitamin Tablets with Hematinics are indicated in the treatment of many of the common iron-deficiency anemias, particularly those associated with nutritional deficiency states or when nutritional requirements are high, and tropical and nontropical sprue. These iron-deficiency states include anemias associated with dietary inadequacy, convalescence, those frequently encountered in late childhood, early adolescence and old age, menorrhagia, and the anemias of women from menarche to menopause including macrocytic or microcytic anemia of pregnancy.
Iron deficiency may result in fatigue, palpitation, smooth and sore tongue, angular stomatitis, dysphagia, gastritis, enteropathy, and koilonychia, as well as anemia. In young children, depressed growth and impaired mental performance occur.
CONTRAINDICATIONS:
Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNINGS:
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Theragran Hematinic Tablets contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
PRECAUTIONS:
General
The use of niacin-containing preparations in patients with gastritis, peptic ulcer, or asthma should be undertaken carefully.
Since iron-deficiency anemia may be a manifestation of a basic systemic disturbance such as recurrent blood loss, the underlying cause of the anemia should be determined and corrected if possible.
The ingredients in Theragran Hematinic are not sufficient nor are they intended for the treatment of pernicious anemia. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive; therefore, the possibility of pernicious anemia should be excluded before treatment with this preparation. Parenteral use of vitamin B12 is recommended to assure essential medical supervision of the patient (see WARNINGS.)
Information for the Patient
Therapeutic Formula Vitamin Tablets with Hematinics and all other medication out of the reach of children.
Patients should be informed of symptoms of intolerance to components of this preparation; if any of these symptoms appear the patient should be advised discontinue dosing, and to notify the physician.
Recommended dosage should not be exceeded unless directed by the physician.
Laboratory Tests
periodic hematologic studies should be performed.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term studies in animals have not been performed.
Pregnancy Category C
Animal reproduction studies have not been conducted with therapeutic formula vitamin tablets with hematinics. Controlled clinical studies have not been performed to determine if therapeutic formula vitamin tablets with hematinics can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. Theragran Hematinic should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether components of this product are excreted in human milk. Because many substances are excreted in human milk, caution should be exercised when Theragran Hematinic is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children have not been established.
DRUG INTERACTIONS:
Since oral iron products interfere with absorption of oral tetracyclines, these products should not be taken within two hours of each other.
Mineral oil and bile-acid sequestrants such as cholestyramine and colestipol hydrochloride in long term therapy have been shown to decrease the absorption of fat-soluble vitamins.
Pyridoxine hydrochloride may act as an antagonist to levodopa.
Hydralazine hydrochloride, penicillamine, isoniazid and cycloserine may antagonize pyridoxine hydrochloride.
Phenytoin, methotrexate, and pyrimethamine may interfere with folic acid absorption.
Colestipol hydrochloride may decrease the bioavailability of niacin.
Vitamin C may decrease the hypoprothrombinemic effect of oral anticoagulants; prothrombin levels should be monitored.
Neomycin and colchicine may impair cyanocobalamin absorption.
ADVERSE REACTIONS:
Allergic reactions, skin rashes, and gastrointestinal disturbances, such as nausea, vomiting, diarrhea, or constipation may occur.
A generalized flushing and a feeling of warmth has been reported following niacinamide therapy.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION:
The usual adult dose is one Therapeutic Formula Vitamin Tablets with Hematinics three times daily. When prescribed in late childhood and early adolescence, dosage reduction according to the size and weight of the child should be considered by the physician. Dosage may be adjusted according to the response of the patient. Since ferrous fumarate is not likely to cause gastric upsets, dosage need not be given at mealtime.